This invention relates to a dental medical oral appliance, and more specifically a drug delivery device for the administration of medicaments orally by means of this appliance. This invention also relates to the methods for treating various oral maladies such as periodontal disease (i.e., gum disease) as well as treating other physical ailments and systemic diseases (e.g., diabetes and other chronic diseases which require either single, intermittent or constant dosing of medicament).
Dental appliances or dental trays have been used in various dental procedures for many years. For example, dental appliances have been used to whiten teeth (See U.S. Pat. No. Re. 34,196 to Munro). Or, dental appliances (referred to as night guards)have been used to prevent patients from grinding their teeth while asleep. They have also been used in conjunction with fluoride as a caries (cavity) preventative. And, dental appliances in conjunction with medication have been used to treat oral pain. (See M. Padilla, C. T. Glenn and M. L. Robert, Topical medications for orofacial neuropathic pain: a review, 131 Journal of the American Dental Association 185 (February 2000).
A general process for preparing these dental appliances is by forming an alginate impression which registers all teeth surfaces in a jaw. Next, a stone cast model is made using the alginate impression of the mouth. In the case of tooth whitening agents, the reservoirs for holding whitening agents are formed by building a layer of rigid material on the teeth surface(s) to be treated of the stone cast (See U.S. Pat. No. 5,985,249).
A dental tray is then vacuum formed from the cast using conventional techniques. Once formed, the tray is trimmed just at the gingival margin on both the buccal and lingual surfaces. The resulting tray provides a perfect fit of the patient""s teeth with pooling reservoirs at the teeth surfaces to be treated.
A disadvantage with the current dental appliances is that these dental appliances deliver compositions to (and thereby treat) only the hard tissues (i.e., teeth) and not to the soft tissues (i.e., periodontium or gums). It is well documented that oral soft tissues readily absorb all types of substances, e.g. nitroglycerine to treat angina. These old dental appliances are limited to treating the patient""s teeth.
In view of the forgoing, it is an object of this invention to provide an oral appliance and drug delivery device that predominantly delivers compositions to the gingival and soft tissues of the mouth.
It is another object of this invention to provide methods and the apparatus for treating oral maladies as well as other physical ailments and systemic diseases.
These and other objects of the invention are accomplished in accordance with the principles of the invention by providing a delivery appliance that extends to the muco-gingival junction. It is maintained that the oral therapeutic delivery appliance would also be effective if it were to be extended beyond to the muco-buccal fold or short of the muco-gingival junction, but would be most effective and comfortable at the muco-gingival junction.
Furthermore, the oral therapeutic delivery appliance contains a therapeutic pooling reservoir at the gingival margin. Once the medicament is placed in the oral therapeutic delivery appliance and the appliance is placed in the patient""s mouth, the medicament will be forced to settle in the therapeutic pooling reservoir due to the snug fit of the appliance to the teeth and the muco-gingiva. As used herein the term medicament includes all medicaments, medicinals and pharmacological agents.
The oral therapeutic delivery appliance stays in the mouth not only mechanically by locking itself about the teeth and soft tissues but also by the suction created by the saliva and the medicament. The tight fit of the oral therapeutic delivery appliance further forces the medicament not only to pool at the gingival margin but also to compress it and force it into the gingival sulcus and into the periodontal pockets. This is precisely where active periodontal disease is and where the medicament will be delivered. It is also an area with tremendous capillary blood flow and absorption.
Further features of the invention, it""s nature and various advantages will be more apparent when viewing the accompanying drawings and the following detailed descriptions of the preferred embodiments.